Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc.

Case Name: Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 923 F.3d 1368, 2019 U.S. App. LEXIS 14345 (Fed. Cir. May 15, 2019) (Circuit Judges Prost, Clevenger, and Wallach presiding; Opinion by Clevenger, J.) (Appeal from D.N.J., Cooper, J.) 

Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen / esomeprazole magnesium); U.S. Patents Nos. 6,926,907 (“the ’907 patent”) and 8,557,285 (“the ’285 patent”)

Nature of the Case and Issue(s) Presented: Non-steroidal anti-inflammatory drugs, also known as NSAIDs, control pain. They also have the undesirable side effect of causing gastrointestinal problems such as ulcers, erosions, and other lesions in the stomach and upper small intestine. To treat the side effect, some practitioners began prescribing acid inhibitors to be taken by a patient along with the NSAID. The NSAID treats the pain while the acid inhibitor reduces the acidity in the gastrointestinal tract, which is achieved by increasing the pH level in the tract. Common acid inhibitors include, among others, proton pump inhibitors (“PPIs”) like omeprazole and esomeprazole. This combination therapy had complications. First, stomach acid degraded the PPI before it could reach the small intestine. To fix that issue, an enteric coating that wears off after a certain amount of time has elapsed was placed around the PPI. Second, if the NSAID was released before the acid inhibitor had enough time to raise the pH level in the tract, patients would continue to suffer gastrointestinal damage. To address those complications, a new drug form was invented that coordinated the release of an acid inhibitor and an NSAID in a single tablet. The tablet contained a core of an NSAID in an amount effective to treat pain, an enteric coating around the NSAID that prevents its release before the pH increases to a certain desired level, and an acid inhibitor like PPI around the outside of the enteric coating that actively works to increase the pH to the desired level. The patents-in-suit cover a NSAID core surrounded by an enteric coating, which in turn is coated by an acid inhibitor outer layer. This design allows the NSAID to delay release until the pill reaches the lower small intestine, to prevent discomfort and gastrointestinal damage. The invention also contemplates an uncoated portion of the pill, allowing for some immediate release.

At trial, the defendants argued that the patents-in-suit were invalid as obvious, not enabled, and not adequately described. Dr. Reddy’s also argued that it did not infringe the ’907 patent because its drug released NSAID at a higher pH than was contemplated in the patents-in-suit. After a bench trial, the district court concluded that the patents-in-suit were valid. The district court also ruled that Dr. Reddy’s product did not infringe the ’907 patent. Defendants appealed on two written description grounds and Plaintiffs appealed the non-infringement determination. On appeal, the Federal Circuit reversed the district court’s written description ruling and dismissed Plaintiffs’ appeal.

Why Defendants Prevailed: The Federal Circuit concluded that the specification provides nothing more than the mere claim that uncoated PPI might work, even though a POSA would not have thought it would work. The specification did not demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work, and thus it does not demonstrate that he actually invented what he claimed: an amount of uncoated PPI that is effective to raise the gastric pH to at least 3.5. The Federal Circuit looked to the inventor’s own testimony where he admitted that he only had a “general concept of coordinated delivery with acid inhibition” using uncoated PPI at the time he filed his first patent application. His only support in the specification for “a rationale explaining why he thought the uncoated PPI would be effective for treating gastric related injury” was that, in its “entire context,” he explained “why the coordinated delivery system would be of benefit for patients.”

Because the Federal Circuit concluded that the patents-in-suit were invalid for failing to describe adequately the efficacy of uncoated PPI, it did not reach the remaining issues on appeal.